Currently, patients with similar type of cancer receive similar treatment, even though the development of a tumor and further progression of the disease is often different in each individual. This traditional approach to cancer treatment has always entailed accepting the risks of individualized adverse reactions, including death, in some cases and inefficiencies that inflate health care costs and undermine patient care.
Additionally, some cancers have few if any options for treatment, and often such treatment options themselves present high levels of toxicity. For example, chemotherapeutic strategies for adrenocortical carcinoma (ACC) carry significant toxicities. Adrenocortical carcinoma is a rare endocrine malignancy (approximately 500 new cases per year in the US) that carries a poor prognosis with advanced disease. Unfortunately a majority of patients will present with advanced disease at the time of diagnosis and once metastatic, the disease has a low (10-20%) five-year survival. For patients with metastatic disease, the only current FDA approved therapeutic is the adrenolytic agent mitotane, with initial response rates of 20-30% in advanced ACC patients and an improvement in survival rate from 14-50 months. Recent years have evaluated mitotane in combination with cytotoxic chemotherapeutics as in the Italian protocol, (etoposide, doxorubicin, cisplatin; EDP) or with streptozocin. EDP-M has been shown to carry a higher response rate (23.2% vs. 9.2%) and progression free survival (5.0 months vs. 2.1 months) compared to mitotane with streptozotocin (Berruti et al., Annals of oncology: official journal of the European Society for Medical Oncology/ESMO. 2012 October; 23 Suppl 7:vii 131-8; Bourdeau et al., Current opinion in endocrinology, diabetes, and obesity. 2013 June; 20(3):192-7; Glover et al., OncoTargets and therapy. 2013; 6:635-43; each of which is herein incorporated by reference in its entirety). Dose-limiting toxicities such as adrenal insufficiency, dizziness, vertigo, central nervous disturbances, hyperlipidemia, and gastrointestinal disorders remain a significant issue with both mitotane and cytotoxic agents given in combination.
What are needed are new and better approaches for cancer management.